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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION
DECISION SUMMARY
ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number:
k062235
B. Purpose for Submission:
Change in volume, strip application port,
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Nicole Stanc - accessdatafdagov is a reporting form used by the FDA to collect information on certain products and activities.
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Manufacturers, distributors, and importers of specific FDA regulated products are required to file nicole stanc - accessdatafdagov.
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